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Opthea becomes ASX top 300 company

Melbourne biopharmaceutical company Opthea has announced its inclusion on the ASX 300, just days after its lead drug candidate met primary end points in the latest clinical trial for diabetic macular edema (DME).

The company has shot to prominence during the past 12 months as it progresses through clinical trials with its VEGF-C/D inhibitor OPT-302 as a combination therapy for neovascular age-related macular degeneration (nAMD) and DME.

As of Monday 29 June, Opthea was trading on the Australian Securities Exchange (ASX) at $2.40, a 258% increase on its $0.67 price exactly a year ago. Its share price peaked last September at $4.

The company’s ASX 300 status, announced on 22 June, now places it among 300 of the largest, highly liquid securities on the ASX by float-adjusted market capitalisation.

“Opthea’s addition to the ASX 300 reflects the company’s strong performance as we have continued to advance our lead product candidate, OPT-302, through the completion of Phase 2 clinical trials in wet age-related macular degeneration and diabetic macular edema,” CEO Dr Megan Baldwin said.

“Our inclusion in the ASX 300 may further diversify the company’s shareholder base as we progress OPT-302 into Phase 3 clinical development.”

Opthea CEO Dr Megan Baldwin says the results support further later stage clinical investigation of OPT-302 in a larger population of DME patients.

Earlier this month, Opthea revealed positive topline results of its Phase 2a randomised, double-masked, sham-controlled trial evaluating the safety and efficacy of OPT-302 administered with Eylea (aflibercept) in treatment refractory patients with persistent DME. It was conducted at 53 sites in the US, Israel, Australia and Latvia and recruited 144 patients.

The trial met the primary efficacy endpoint with 52.8% of patients achieving a ≥ 5 letters gain in best corrected visual acuity (BCVA) at week 12. The co-primary endpoint of safety was also met with 2.0 mg OPT-302 in combination with 2.0 mg Eylea being well tolerated with a similar safety profile to the Eylea + sham (control) group.

“These Phase 2a data are very promising given that dual-targeted inhibition of VEGF-C/D and VEGF-A with OPT-302 combination therapy demonstrated biological activity across multiple vision and anatomical endpoints which may lead to improved outcomes in the management of DME,” US-based study investigator Dr David Boyer said.

“With limited treatment options currently available and many patients who do not adequately respond to anti-VEGF-A therapies, there remains a significant unmet need for more efficacious and durable therapies for DME. If we could add a treatment such as OPT-302 to potentially improve vision in this population of hard to treat patients, this would be significant.”

Further trials warranted

In a separate Phase 2b study read out last August, Opthea demonstrated the benefits of its therapy for nAMD patients. In that trial, patients treated with OPT-302, in conjunction with ranibizumab (Lucentis), had superior visual acuity compared with those who received Lucentis alone.

“These positive topline Phase 2a results in a second disease indication of DME, build on our extensive prior clinical studies in wet AMD which demonstrated superiority in visual improvement with OPT-302 combination therapy compared to anti-VEGF-A monotherapy standard of care,” Baldwin said.

“The intent of this proof-of-concept study was to generate directional information on the safety, tolerability and therapeutic potential of OPT-302 combination therapy for DME. This trial was conducted in a difficult to treat refractory DME patient population, and these early results support further later stage clinical investigation of OPT-302 in a larger population of patients with DME.”